Devices and methods for sensing physiological signals during stimulation therapy

ABSTRACT

Devices and methods provide for the sensing of physiological signals by providing a stimulation waveform that includes a stimulation pulse followed by an active recharge pulse to clear the charge in capacitors within the stimulation path. The active recharge pulse is followed by a period of passive recharge and then a period of no recharge. Non-neurological sources of artifacts within the sensed physiological signal may be handled by providing a brief period of passive recharge followed by a lengthy period of no recharge, which is made possible by the use of the active recharge pulse prior to the passive recharge. The period of no recharge removes any low impedance path to ground from the stimulation electrodes, which allows an amplifier of the sensing circuit to provide common mode rejection of non-neurological signals, such as cardiac signals, present at the sensing electrodes.

RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 15/444,997, filed on Feb. 28, 2017.

TECHNICAL FIELD

Embodiments provide devices and methods for sensing physiologicalsignals. More particularly, embodiments provide devices and methods forsensing physiological signals while stimulation therapy is beingconducted.

BACKGROUND

Electrical stimulation therapy may be used for various forms oftreatment. For example, stimulation therapy may be provided to addressneurological issues such as chronic pain, tremors, and the like. In suchan example, an implantable stimulation device is typically located inone location of convenience and is connected to electrical leads thatare routed to a stimulation site such as within the brain, within thespinal column, within the pelvic region, or elsewhere. The electricalleads include electrodes that interface with the tissue at thestimulation site to deliver the stimulation signals from the stimulationdevice.

It may be useful to also sense physiological signals nearby thestimulation site. Such signals may be useful to tailor the stimulationtherapy to the particular condition being treated and/or to betterunderstand the response of the tissue nearby the stimulation site to thestimulation signals. Sensing physiological signals may be especiallyuseful where the stimulation therapy may be at least partiallycontrolled based on the physiological signals.

Sensing physiological signals in proximity to the stimulation site canbe problematic particularly for neurological stimulation systems. Othersignals that may be present within the body nearby the stimulation sitemay have a voltage that is orders of magnitude greater than theneurological signal to be sensed. For instance, electrical signalsproduced by the cardiac system can be very problematic considering theheart may be located in close proximity to the neurostimulation deviceand leads, especially in the case of deep brain stimulation therapy whenthe device is located in the upper torso.

SUMMARY

Embodiments address issues such as these and others by providing devicesand methods that reduce the likelihood of non-neurological signalsproducing unwanted artifacts in the sensed physiological signals. Someembodiments provide for active recharge to occur after the stimulationpulse and then passive recharge to occur briefly after the activerecharge. The recharge is then turned off for the remainder of theperiod occurring before the next stimulation pulse which provides anadequate amount of time to sense the physiological signals of interest,such as neurological signals. While the recharge is off, there is no lowimpedance path to the device ground potential which prevents anysignificant amount of cardiac or other non-neurological produced currentfrom flowing through signal pathways leading to differential inputs ofthe sensing amplifier. As a result, the non-neurological signal presentsessentially the same voltage across both differential inputs of thesensing amplifier such that common mode rejection of thenon-neurological signal occurs.

Embodiments provide a method of providing stimulation and sensingphysiological signals that involves providing a first stimulation pulsefrom a first electrode within a body and after the first stimulationpulse terminates, providing an active recharge pulse from the firstelectrode. The method further involves after a termination of the activerecharge pulse, providing a passive recharge from the first electrodeand after a termination of the passive recharge, providing no rechargefor a period of time. The method also involves during at least a portionof the period of time of no recharge, sensing physiological signals froma second electrode within the body and after the period of time of norecharge, providing a second stimulation pulse from the first electrode.

Embodiments provide an implantable medical device that includes astimulation output and a stimulation engine that provides a waveform tothe stimulation output, the waveform including a stimulation pulsefollowed by an active recharge pulse followed by a passive rechargefollowed by a period of time of no recharge. The implantable medicaldevice further includes a first sensing input and a differentialamplifier connected to the first sensing input. The implantable medicaldevice also includes a controller that obtains physiological signalsfrom the differential amplifier during at least a portion of the periodof time of no recharge, the controller causing the stimulation engine toproduce the waveform repeatedly.

Embodiments provide an implantable medical system that includes at leastone implantable medical lead comprising a first electrode and a secondelectrode. The implantable medical system further includes animplantable medical device that has a stimulation output electricallycoupled to the first electrode. The implantable medical system alsoincludes a stimulation engine that provides a waveform to thestimulation output. The waveform includes a stimulation pulse followedby an active recharge pulse followed by a passive recharge followed by aperiod of time of no recharge. The implantable medical system alsoincludes a first sensing input electrically coupled to the secondelectrode and a differential amplifier connected to the first sensinginput. The implantable medical system includes a controller that obtainsphysiological signals from the differential amplifier during at least aportion of the period of time of no recharge, and the controller causesthe stimulation to produce the waveform repeatedly.

DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a patient having an example of an implantable medicalsystem for sensing physiological signals concurrently with providingstimulation signals according to various embodiments.

FIG. 2 shows an implantable medical system including a medical deviceattached to a stimulation lead and a sensing lead or to a sensing andstimulation lead.

FIG. 3 shows an example of sensing circuitry of a medical device thatimplements active recharge, passive recharge, and a large period of norecharge.

FIG. 4 shows a first example of a stimulation waveform including activerecharge, passive recharge, and a large period of no recharge and with acorresponding sensing state.

FIG. 5 shows a first stimulation engine circuit configuration used forproviding the stimulation pulse portion of the stimulation waveform.

FIG. 6 shows a second stimulation engine circuit configuration used forproviding the active recharge pulse portion of the stimulation waveform.

FIG. 7 shows a third stimulation engine circuit configuration used forproviding the passive recharge portion of the stimulation waveform.

FIG. 8 shows a fourth stimulation engine circuit configuration used forthe period of no recharge of the stimulation waveform.

FIG. 9 shows a set of logical operations to determine an appropriateactive recharge pulse amplitude ratio relative to the stimulation pulseamplitude in order to minimize non-neurological signals being amplifiedduring sensing.

FIG. 10 shows an equivalent circuit of the non-neurological signalsource and inputs to a differential amplifier of the sensing circuitryof the medical device when the stimulation engine is providing passiverecharge for the stimulation node.

FIG. 11 shows an equivalent circuit of the non-neurological signalsource and inputs to a differential amplifier of the sensing circuitryof the medical device when the stimulation engine is providing a periodof no recharge to create common mode rejection of the non-neurologicalsignal source.

FIG. 12A shows a spectrogram of a sensed neurological signal where thestimulation waveform utilizes only a lengthy passive recharge andsignificant cardiac energy is present in the sensed signal.

FIG. 12B shows a spectrogram of a sensed neurological signal where thestimulation waveform utilizes a brief active recharge followed by alengthy passive recharge and significant cardiac energy is present inthe sensed signal.

FIG. 12C shows a spectrogram of a sensed neurological signal where thestimulation waveform utilizes a substantial active recharge followed bya brief passive recharge and cardiac energy is present in the sensedsignal.

FIG. 13 shows a set of logical operations to determine whether toimplement active recharge followed by passive recharge and a period ofno recharge.

FIG. 14 shows a sensed signal and a detection signal based on the sensedsignal and a threshold.

DETAILED DESCRIPTION

Embodiments provide medical devices and related methods that minimizethe presence of non-neurological signal artifacts on a sensed signal.Embodiments utilize a stimulation waveform that includes an activerecharge period followed by a passive recharge period and then a periodof no recharge where sensing is performed at least during the period ofno recharge. Some embodiments determine whether there arenon-neurological signal artifacts present in the sensed signal whileusing passive recharge without active recharge and then switch to usingactive recharge followed by passive recharge when non-neurologicalsignal artifacts are present. Furthermore, some embodiments optimize theratio of active recharge amplitude to stimulation pulse amplitude tofurther minimize the artifacts.

FIG. 1 shows an example of an operating environment for the variousembodiments. An implantable medical system 100 is implanted within abody of a patient 112. The implantable medical system 100 includes astimulation and sensing device 102 coupled to a stimulation lead 104.The stimulation and sensing device 102 includes a conductive outercasing 106 as well as a header 108 that includes a bore where a proximalend of the stimulation lead 104 is positioned. The stimulation lead 104includes a lead body 109 and one or more electrodes 110 on a distal endof the lead body 109 which is positioned at a stimulation site withinthe body of the patient 112. The stimulation device 102 producesstimulation signals that are delivered through conductors of thestimulation lead 104 to the electrodes 110 where those stimulationsignals enter the tissue of the patient 112.

In this example, the header 108 also includes a bore where a proximalend of a sensing lead 114 is positioned. The sensing lead 114 includes alead body 116 and one or more electrodes 118, 120 that are positioned inproximity to the stimulation site within the body of the patient 112 soas to be able to capture physiological signals emanating from thestimulation site. The stimulation and sensing device 102 provides a modeof capacitor recharge and senses the physiological signals whennon-neurological signals may be present within the patient 112.

The foregoing example provides stimulation lead 104 dedicated toproviding the stimulation signal and sensing lead 114 dedicated tosensing the physiological signal. In still another example, the same oneor more leads may be used to provide both the stimulation and sensingfunction. For instance, one or more electrodes of a single lead may beused to deliver stimulation signals to the tissue of patient 112 and oneor more different electrodes of that same lead may be used to sensephysiological signals emanating from the stimulation site.Alternatively, multiple electrodes residing on multiple leads may beused to deliver the stimulation signals while one or more electrodesprovided by one or both of the multiple leads may be used to sense thephysiological signals. In such cases, the lead is electrically connectedto both the stimulation engine and the sensing circuit, this optionbeing shown as dashed lines in FIG. 2 discussed below. In some examples,a same electrode used to provide stimulation signals may be used toperform sensing. In such examples, one or more switches may be used toselectively connect the stimulation engine 206 and sensing circuit 204to the same electrode. For instance, the stimulation engine 206 may bedisconnected from the electrode prior to connecting the sensing circuit204 to the electrode, and so on. In such a case, the switch of theelectrode to sensing mode begins once recharge has completed such thatthe electrode is no longer involved in providing the recharge path.

The one or more leads used for providing the stimulation signals and forsensing the physiological signals may be of various types. In oneexample, a lead having a simple electrode array geometry may be used forstimulation and/or for sensing. An example of a simple electrode arraygeometry may include one or more ring electrodes distributed atdifferent axial positions along the length of a lead. Another example ofa simple electrode array geometry is a planar array of electrodes on apaddle lead such as for spinal stimulation sites.

In another embodiment, one or more leads used for providing thestimulation signal and for sensing the physiological signals may have acomplex electrode array geometry. A complex electrode array geometrygenerally refers to an arrangement of stimulation electrodes at multiplenon-planar or non-coaxial positions, in contrast to simple electrodearray geometries in which the electrodes share a common plane or acommon axis. An example of a complex electrode array geometry, inaccordance with this disclosure, is an array of electrodes positioned atdifferent axial positions along the length of a lead, as well as atdifferent angular positions about the periphery, e.g., circumference, ofthe lead. In some embodiments, the electrodes in the complex arraygeometry may appear similar to non-contiguous, arc-like segments of aconventional ring electrode. A lead with a complex electrode arraygeometry may include multiple “rings” of such electrode segments. Eachring is disposed at a different axial position. Each electrode segmentwithin a given ring is disposed at a different angular position. Thelead may be cylindrical or have a circular cross-section of varyingdiameter. Such a lead may be referred to as a “segmented” lead.

Another example of a complex electrode array geometry is an array ofelectrodes positioned on multiple planes or faces of a lead. As anillustration, arrays of electrodes may be positioned on opposite planesof a paddle lead or multiple faces of a lead having a polygonalcross-section, particularly for spinal stimulation sites. Examples ofcomplex array geometries are shown and described in U.S. Pat. No.7,822,483 entitled “Electrical and Activation Field Models forConfiguring Stimulation Therapy” which is assigned to the assignee ofthe present application and which is incorporated herein by reference.Other types of sensing and/or stimulation electrodes may be usedaccording to the current disclosure, including conformable electrodes,cuff electrodes, segmented electrodes, or any other type of electrodescapable of forming unipolar, bipolar or multi-polar electrodeconfigurations.

The stimulation signals may be delivered using various electrodearrangements such as unipolar arrangements, bipolar arrangements ormultipolar arrangements. A unipolar stimulation arrangement generallyrefers to the use of an anode on the conductive outer casing 106 thatsources current and one or more cathodes on one or more leads (e.g.,104, 114) that sink current. A bipolar stimulation arrangement generallyrefers to the use of an anode on a lead (e.g., lead 104) that sourcescurrent and a cathode on the same lead and/or another lead that sinkscurrent. A multipolar stimulation arrangement generally refers to theuse of more than one anode on a lead (e.g., lead 104) that each sourcecurrent and one or more cathodes on the same lead or another lead thatsink current, or the use of one anode on a lead that sources current andmultiple cathodes on the same lead or another lead that sink current.

A hybrid stimulation arrangement that combines both unipolar and bipolarelectrode relationships may be referred to as an omnipolar arrangement.In an omnipolar arrangement, an anode on the housing may be used todeliver stimulation pulses substantially simultaneously with at leastone anode on a lead and at least one cathode on a lead. In this case,for an omnipolar arrangement, at least one anode on a lead and at leastone anode on the housing can be used simultaneously in combination withat least one cathode on a lead. In other omnipolar arrangements, acathode on the housing may be used to deliver stimulation pulsessubstantially simultaneously with at least one cathode on a lead and atleast one anode on a lead. In this alternative case, for an omnipolararrangement, at least one cathode on a lead and at least one cathode onthe housing can be used simultaneously in combination with at least oneanode on a lead. Any of the above electrode arrangements, or otherelectrode arrangements, may be used to deliver electrical stimulation inaccordance with techniques described in this disclosure.

FIG. 2 shows the implantable medical system 100 in more detail. Here,the stimulation device 102 includes a stimulation engine 206, a sensingcircuit 204, and a controller 202. A conventional stimulation engine 206produces the stimulation pulses and recharge pulses applied to thestimulation pathway via electrical connections 210 to the stimulationlead 104 within the header block 108. The sensing circuit 204 capturesthe physiological signals via connections 208 to the sensing lead 114within the header block 108. In an embodiment where the sensing andstimulation function are provided by one or more of the same leads, boththe stimulation engine 206 and sense circuit 204 may be coupled to thesame one or more leads, as appropriate. Such an option is illustratedfor the lead 114 of FIG. 2 with a dashed line indicating the optionalelectrical connection of the stimulation engine 206 being electricallyconnected to the lead 114 where one of the electrodes 118 or 120 isbeing used for stimulation while the other electrode is being used forsensing.

Stimulation engine 206 may provide voltage-controlled stimulation orcurrent-controlled stimulation during various forms of therapy. Aspecific example of electrical stimulation parameters and correspondingranges for the stimulation engine 206 to implement that are believed tobe effective in deep brain stimulation (DBS) therapy to manage amovement disorder of a patient includes: 1. Frequency: the stimulationsignal can include signal components within a first range offrequencies, for example, between approximately 0 Hz and approximately10,000 Hz, or in some examples between approximately 0 Hz andapproximately 500 Hz, or between approximately 2 Hz and approximately250 Hz. 2. Voltage Amplitude: between approximately 0 volts andapproximately 50 volts, such as between approximately 0 volts andapproximately 25 volts. 3. Current Amplitude: A current amplitude may bebetween approximately 0 milliAmps and approximately 40 milliAmps, orapproximately 0 to 25 milliAmps. 4. Pulse Width: between approximately 1microseconds and approximately 5000 microseconds, such as betweenapproximately 10 microseconds and approximately 1000 microseconds, orbetween approximately 10 microseconds and approximately 450microseconds.

The sensing circuit 204 may capture the physiological signals inproximity to the stimulation site by avoiding the stimulation signal.For instance, the sensing circuit 204 may utilize blanking during thestimulation signal as well as during the active recharge portion, ifany, after the stimulation signal. The stimulation pulse and activerecharge pulse therefore do not negatively impact the sensing circuit204 such that the sensing circuit 204 can capture accurate physiologicaldata during the time between the stimulation pulses.

In this example, the controller 202 orchestrates the operation of thesensing circuit 204 and the stimulation engine 206. The controller 202activates and deactivates various phases of operation of the stimulationthat occur during stimulation therapy. The phases may include astimulation output phase where the stimulation pulse is delivered, and arecharge phase that clears voltage on coupling capacitors in thestimulation path within the stimulation engine 206. The phases may alsoinclude a period of no recharge. Likewise, the controller 202 activatesblanking switches of the sensing circuit 204 to blank the stimulationsignal and at least a portion of a passive recharge signal such as thepeak of the passive recharge signal when a passive recharge signal isused alone. For an active recharge pulse followed by a brief passiverecharge signal followed by a lengthy period of no recharge, some of thepassive recharge signal may be blanked in addition to blanking some orall of the active recharge pulse, depending upon the desired amount oftime to sense the physiological signal.

The controller 202 may be of various forms. For instance, the controller202 may comprise a general purpose programmable processor thatimplements programming instructions to bring about the operation of thestimulation engine 206 and the sensing circuit 204. As other examples,the controller 202 may comprise a dedicated purpose processor and/orhardwired digital logic.

FIG. 3 shows an example of the sensing circuit 204 that blanks thestimulation pulse as well as some or all of the active recharge pulse,if any. Each sensing electrode 118, 120 is electrically coupled to ablanking switch 302, 304 that is controlled by the controller 202. Theblanking switches may be implemented in silicon such as individualtransistors or in more complex arrangements as discussed below. Thecontroller 202 provides a blanking control signal 306, 308 that causesthe switches to either conduct signals or stop conducting the signalsfrom the electrodes 118, 120. The switches 302, 304 conduct from a timeafter the recharge phase to a time before the beginning of the nextstimulation phase and stop conducting at least during the stimulationphase and the peak of the following recharge phase in order to blank thestimulation artifacts from the sensed signal.

The blanking switches 302, 304 may be followed in the respective signalpath by filters 310 that include both high pass and low pass filtersthat remove extraneous frequencies from the sensed signal. The filteredsignals are provided as input to conventional differential amplifiers312 that scale the amplitude as desired to produce the sensed signaloutput 314. The filters 310 may include a high pass filter to decouplefrom DC which can occur during the blanking period. The filters 310 mayinclude a low pass filter to avoid waveform spread and to avoid arectification effect from high frequency interferences.

FIG. 4 shows a set of signals and their related timing including astimulation therapy waveform 400 and a blanking control signal 420. Ascan be seen, the stimulation therapy waveform 400 includes a stimulationpulse 402 having a pulse width PW_(S), followed by a relatively briefoff period 404 (e.g., 64-96 μs) then followed by an active rechargepulse 406 of opposite polarity. By using active recharge, the rechargepulse 406 may be provided with a steady amplitude rather than decayinglike a passive recharge pulse. The active recharge pulse 406 may alsohave a larger amplitude than the peak of a passive recharge pulse, thusthe amount of time to provide the recharge to clear the capacitors isdrastically reduced. Furthermore, it is beneficial to the elimination ofthe artifacts from a non-neurological signal to clear the capacitorsprior to sensing the physiological signal. Therefore, as in thisexample, the active recharge pulse 406 is provided very soon after theend of the stimulation pulse 402.

The blanking control signal 420 is held at an amplitude that biases theblanking control switches to the conducting state to allow current flow.However, the blanking control signal 420 includes an inverted pulse 422that unbiases the blanking control switches from the conducting state tothe non-conducting state to prohibit current flow. The blanking controlsignal 420 is synchronized in time to the stimulation waveform 400 suchthat the blanking control signal inverted pulse 422 begins just beforethe stimulation pulse 402 and terminates just after the recharge pulse406. The blanking control signal inverted pulse 422 thereby causescurrent flow to be blocked during the entire stimulation pulse 402 andat least a large portion of the active recharge pulse 406.

The active recharge pulse 406 has a pulse width PW_(AR) that may bepegged to the pulse width of the stimulation pulse 402. The amplitude ofthe active recharge pulse 406 may then be set to effectively clear thecapacitors in the amount of time of the pulse width. As noted above,clearing the capacitors assists in eliminating the signal artifacts. Onemanner of ensuring this to be the case is to set the active rechargeamplitude to some ratio of the stimulation pulse amplitude, measure thesensed signal, adjust the ratio, and repeat until the signal artifactsare minimized. This is discussed in more detail below with reference toFIG. 9.

Once the active recharge pulse 406 has completed, and after a very briefperiod 408 (e.g., 8-12 μs) of no recharge 408 has occurred while passiverecharge switches of the stimulation engine transition to a conductivestate, a period of passive recharge 410 occurs. The passive recharge 410finishes the balancing of the capacitors to fully prepare the capacitorsfor the next stimulation pulse which avoids loss of stimulationamplitude and avoids any charge neutrality issues. The duration of thepassive recharge 410, T_(PR), may be set to a particular fixed value(e.g., 264-396 μs) and then allow the active recharge ratio to beadjusted, in light of that fixed duration of passive recharge, toeffectively clear the capacitors and minimize signal artifacts.

A relatively lengthy period of no recharge 412 then follows the periodof passive recharge 410. The period of no recharge 412 has a durationT_(NR) that is equal to the amount of time available between the end ofthe passive recharge 412 and the beginning of the next stimulationpulse. This next stimulation pulse occurs in accordance with the givenrate of stimulation currently being used by the stimulation engine.

At some point near the end of the active recharge pulse 406 and thebeginning of the period of no recharge 412, the blanking switches arereversed as indicated by the reversal of the state of the blankingsignal 420 at signal portion 424. During signal portion 424, theblanking switches conduct the received signal to allow for capturing andamplifying the sensed signal. Thus, the sensed signal is being capturedand amplified at least during the period of no recharge 412. In someembodiments, the sensed signal may also be captured and during some orall of the passive recharge 410 and potentially during an ending portionof the active recharge pulse 406 or off period 408.

FIGS. 5-8 illustrate examples of circuit configurations that thestimulation engine may utilize to bring about each of the phases of thestimulation waveform 400 of FIG. 4. FIG. 5 specifically shows theconfiguration for producing the stimulation pulse 402. The stimulationengine of this example includes a first current source 502 that forcescurrent through a first capacitor 506 of the stimulation path, throughthe tissue of the body where the stimulation electrodes are located(e.g., the resistance provided by the brain, R_(BRAIN)), and throughanother capacitor 508 of the stimulation path. A second current source504 pulls this current to system ground. While multiple current sourcesa 502, 504 are shown, it will be appreciated that a single currentsource may be used instead. Additionally, while current sources areshown in FIG. 5, it will be further appreciated that one or more voltagesources may be used instead.

FIG. 6 specifically shows the configuration for producing the activerecharge pulse 406. The stimulation engine of this example includes afirst current source 602 that forces current in the opposite directionas the current sources 502, 504 of FIG. 5 and through the secondcapacitor 508 of the stimulation path, through the tissue of the body(e.g., R_(BRAIN)), and through the first capacitor 506 of thestimulation path. A second current source 604 pulls this current tosystem ground. While multiple current sources a 602, 604 are shown, itwill be appreciated that a single current source may be used instead.Additionally, while current sources are shown in FIG. 6, it will befurther appreciated that one or more voltage sources may be usedinstead.

FIG. 7 specifically shows the configuration for providing the period ofpassive recharge 410. Here the, stimulation engine grounds bothstimulation paths to thereby short both capacitors 506, 508 to groundvia a low impedance path. As discussed below in relation to FIG. 10, itis this low impedance path that can allow artifacts fromnon-neurological sources such as an ECG signal of the cardiac system tobe captured and amplified. Therefore, this phase is minimized, forinstance to a minimal fixed amount such as 264-396 μs, as discussedabove in relation to FIG. 4,

FIG. 8 specifically shows the configuration for providing the period ofno recharge 412. Here, the stimulation engine allows both stimulationpaths to electrically float by providing no electrical connection to anyparticular voltage potential. It is this high impedance path to systemground that results in common mode rejection of the non-neurologicalsignals at the differential amplifier of the sensing circuit.

FIG. 9 shows a set of logical operations that may be used by thecontroller 202 to set the active recharge ratio that was discussedabove. The active recharge ratio of this example sets the amplitude ofthe active recharge pulse 406 to be some percentage of the amplitude ofa baseline active recharge pulse, the baseline typically being theamplitude of the stimulation pulse 402, in order to best clear thecapacitors 506, 508 of the stimulation path from the standpoint ofminimizing artifacts in the sensed signal. Initially, the stimulationwaveform 400 is utilized repeatedly at operation 902, with eachiteration using a different active recharge ratio. For example, thefirst iteration may use a ratio of 0.8, the second may use 0.9, thethird may use 1, the fourth may use 1.1, and the fifth may use 1.2.

Once the set of active recharge ratios have each been used, thepeak-to-peak amplitude of each resulting sensed signal is measured at anoperation 904. The controller 202 then selects the active recharge ratiothat produced the smallest peak-to-peak amplitude of the sensed signalat an operation 906. The stimulation engine then begins producing thestimulation waveform 400 using the selected active recharge ratio to setthe amplitude of the active recharge pulse 406 at an operation 908. Thestimulation engine may then proceed indefinitely, such as until theimplantable medical device 102 receives programming that causes thecontroller 202 to change the stimulation waveform 400 in some manner,which may then trigger the controller 202 to employ the operations ofFIG. 9 again to set the active recharge ratio unless the programming hasalready specified what the active recharge ratio should be.

Another example, indicated by the dashed operational flow of FIG. 9leading to the operation 910, accounts for the possibility thatphysiological and device variables may drift over time such that adifferent active recharge ratio may eventually be the better choice. Inthis example, the controller 202 may allow the stimulation waveform 400to continue at the selected active recharge ratio until a set amount oftime has been reached from the time the active recharge ratio wasinitially selected, such as 24 hours. At that point, the controller 202may repeat the operations 900 of FIG. 9 to again find the activerecharge ratio that minimizes the peak-to-peak amplitude and then selectthat active recharge for use for the next period of time measured atoperation 910.

FIG. 10 shows an equivalent circuit 1000 that models a passive rechargeconfiguration. The circuit includes a non-neurological source, such asthe heart 1002, and the electrical pathway through the body to nodes1016, 1018 (e.g., sensing electrodes 118, 120) of the differentialamplifier 1020 of the sensing circuit and to a node 1014 (e.g.,stimulation node 110) of the stimulation pathway. Resistances 1004,1006, 1008, and 1010 represent the tissue located between the variousnodes. This resistance is typically in the range of 1.5 kilo-ohms. Inthis passive recharge configuration, the stimulation pathway node 1014is connected to ground, as in FIG. 7. Thus, there is an electricalpathway that is established where current flows from the heart 1004 andthrough the tissue resistance 1004 to the sensing node 1016.

Considering the amplifier input of node 1016 does not short to ground,the electrical pathway continues through the tissue resistance 1006 to acentral node 1012, which has essentially the same voltage as the sensingnode 1018 since there is little to no current through tissue resistance1010 due to the large input impedance of the amplifier 1020 at node1018. The electrical pathway continues from central node 1012 throughadditional tissue resistance 1008 to the stimulation node 1014 which isat system ground. Thus, this flow of current produced by the heart 1002results in a first voltage on node 1016 while a second voltage occurs onthe node 1018. The voltage (VE2) for node 1016 and the voltage (VE0) fornode 1018, shown as Eq. 2, are a function of the voltage (VHeart) of theheart 1002 and the resistances of the tissue 1016, 1018 (Rtissue) andthe resistance of device leakage 1004 (Rleakage). The voltage (VE2) onnode 1016 and the voltage (VE0) on node 1018 are shown below as Eq. 1and Eq. 2, respectively:

VE2=VHeart*(2*Rtissue)/(Rleakage+(2*Rtissue))  (Eq. 1)

VE0=VHeart*(Rtissue)/(Rleakage+(2*Rtissue))  (Eq. 2)

As can be seen from Eq. 1 and Eq. 2, the voltage on node 1018 is half ofthe voltage on node 1016. Considering the differential amplifier 1020amplifies the difference between the signal at node 1016 and the signalat 1018, there is a significant amount of the cardiac signal beingamplified. FIGS. 12A, 12B, and 12C discussed in more detail below showthe results of using this configuration alone, in combination withactive recharge but without a period of no recharge, and finally withactive recharge, a very brief period of passive recharge, and then alengthy period of no recharge.

FIG. 11 shows an equivalent circuit 1100 that models a configuration forthe period of no recharge. The circuit includes the non-neurologicalsource, such as the heart 1002, and the electrical pathway through thebody to sensing nodes 1016, 1018 and to stimulation node 1014. However,in this no-recharge configuration, the stimulation pathway node 1014 isallowed to electrically float, as in FIG. 8. Thus, there is no longer alow impedance electrical pathway that is established where current canflow from the heart 1004 and through the tissue resistance 1008.

The differential amplifier 1020 has input impedance at the respectivedifferential inputs represented as resistances 1102 and 1104. These aretypically in the mega-ohm range, such as 2 mega-ohms. While these inputimpedances are also present in the passive recharge configuration 1000of FIG. 10, the low impedance path from node 1014 to ground renders themirrelevant to the voltages at nodes 1016 and 1018. However, in theno-recharge configuration 1100 of FIG. 11, allowing the node 1014 tofloat results in current only passing into the inputs of thedifferential amplifier 1020. Therefore, these input impedances arerelevant.

Considering these input impedances are drastically larger than thoseresistances presented by the tissue in the signal path, specificallyresistances 1006 and 1010 between nodes 1016 and 1018, the voltagepresent on node 1016 is essentially the same as the voltage present onnode 1018. The voltage on node 1016 is essentially a function of thevoltage (VHeart) of the heart 1002, the leakage resistance 1004(Rleakage), and the amplifier input impedance 1102 (Rinput). The voltageon node 1018 is essentially a function of the voltage (VHeart) of theheart 1002, the leakage resistance 1004 (Rleakage), the amplifier inputimpedance 1104 (Rinput), and the tissue resistance 1006, 1010(2*Rtissue). Therefore, the voltage (VE2) on nodes 1016 and the voltage(VE0) on node 1018 are as follows in Eq. 3 and Eq. 4, respectively:

VE2=VHeart*(Rinput)/(Rleakage+Rinput)  (Eq. 3)

VE0=VHeart*(Rinput)/(Rleakage+(2*Rtissue)+Rinput)  (Eq. 4)

One can see that the difference between the sensing electrodes istrivial, with the difference being only the result of adding the doubletissue resistance in the denominator. This addition to the denominator,which is an addition of approximately 3 kilo-ohms, is insignificant incomparison with the larger numerator that contains the approximately 2mega-ohm input resistance. Considering only this trivial differenceexists, the cardiac signal is presented primarily as a common modesignal between the two sensing electrodes and therefore common moderejection of the cardiac signal by the amplifier 1020 occurs.

In the configurations of FIGS. 10 and 11, the physiological signal to becaptured, namely the neurological signal emanating from the target site,will present a significant difference from one sensing node 1016 to theother 1018. This physiological signal to be captured propagates from anarea near one sensing electrode toward the other, which results in adifferential signal between the two sensing electrodes. Thisdifferential signal is amplified by the differential amplifier 1020 andultimately provided to the controller 202 as the sensed signal where thesignal may be used for subsequent purposes or stored for laterretrieval.

FIGS. 12A-12C show spectrograms of the sensed signal that has beenamplified by the differential amplifier 1020. Frequency is representedalong the vertical axis while time is presented along the horizontalaxis. As illustrated, the trace illustrates the frequencies of mostintensity. FIG. 12A shows a spectrogram 1202 demonstrating the result ofusing only passive recharge. FIG. 12B shows a spectrogram 1206demonstrating the result of using a brief active recharge with a lengthypassive recharge that extends until time for the next stimulation pulse.As can be seen in both of these spectrograms 1202 and 1206, there issignificant cardiac energy spanning significant frequencies (e.g., up to100 Hz), as illustrated by the vertical spikes. The spikes representingthe presence of cardiac energy are apparent in areas indicated byellipses 1204 and 1208. These intensities of cardiac energy appear inthe amplified signal due to the condition shown in FIG. 10.

Transitioning to the spectrogram 1210 of FIG. 12C, according to thestimulation waveform 400 of FIG. 4 where passive recharge is only brief,e.g. 330 μs, there is such a small amount of time of passive rechargethat little to no cardiac energy is being captured. Thus, theno-recharge circuit configuration 1100 of FIG. 11 dominates the periodof sensing, and because common mode rejection is taking place during thecorresponding lengthy period of no recharge, the cardiac energy iseliminated from the sensed signal. The lack of cardiac energy isevident, as there are no longer vertical spikes in the trace in the areaindicated by the ellipse 1212.

Utilizing active recharge to more quickly clear the capacitors allowsfor the lengthy period of no recharge shown in FIG. 12C. However, activerecharge requires energy to be provided by the implantable medicaldevice 102. As discussed above and shown in FIG. 6, current sources 602and 604 force current through the stimulation path capacitors 506, 508in the reverse direction to more quickly clear the charge that hasaccumulated during the stimulation pulse. Thus, active recharge mayreduce the amount of charge in the battery of the implantable medicaldevice more quickly than if only passive recharge is being used.

To account for this increased drain on the battery, some embodiments ofthe implantable medical device 102 may utilize logical operations likethe example 1300 of FIG. 13 to determine whether the active recharge isneeded. Due to changes in device condition, patient physiology, and soforth over time, the likelihood of cardiac energy being captured asartifacts in the sensed signal may fluctuate. Therefore, active rechargemay be utilized only when necessary to eliminate the unwanted artifactsaccording to the example 1300.

These logical operations begin by the controller 202 obtaining a sensedsignal while using a stimulation waveform that includes lengthy passiverecharge at an operation 1302. At this point, this waveform may eitherbe using only passive recharge, such as where active recharge has notyet been required, or may already include both active recharge andpassive recharge. However, for implementing this detection process, theperiod of passive recharge should be significant so that a window forsensing during the passive recharge period allows a significant numberof cycles of the non-neurological source. For instance, the passiverecharge may be active for 15 seconds to ensure that at least 10heartbeats have occurred during that period of passive recharge.

Once the sensed signal has been obtained, the controller 202 applies adetection threshold to produce a detection signal at an operation 1304.FIG. 14 shows an example of the sensed signal 1402 and the detectionthreshold 1406. The detection threshold is set to some amplitude that islower than the peak of the non-neurological artifact 1408 present in thesensed signal 1402 but higher than peaks of the neurological signalwithin the sensed signal 1402. Application of the detection thresholdproduces the detection signal 1404, which includes a pulse 1410 for eachinstance of the sensed signal 1402 exceeding the detection threshold1406.

Upon obtaining the detection signal 1404, the controller 202 computesthe average interval (T_(AVE) of FIG. 14) between the detection signalpulses for a set number of pulses, e.g., 10, at an operation 1306. Thisaverage interval may then be compared to a range defining a span typicalfor the non-neurological signal of interest. For instance, a typicalpulse rate has anywhere from a 0.375 second interval (i.e., 160 beatsper minute) to a 1.5 second interval (i.e., 40 beats per minute). Asdetermined by the controller 202 at a query operation 1308, if theaverage interval falls outside of the range which indicates that thedetection signal is likely not produced by the non-neurological sourceof interest, then the controller 202 utilizes a mode where only passiverecharge is used at an operation 1312. When the average interval doesfall within the range, then the controller 202 utilizes the mode thatincludes active recharge, followed by a brief period of passiverecharge, followed by a lengthy period of no-recharge at an operation1310.

In one embodiment of the example 1300, the logical operations end andthe device continues to use the selected mode indefinitely. Forinstance, the mode may be continued until an external programmerinstructs the controller 202 to repeat the operations 1300. In anotherembodiment, shown with the dashed lines of the operational flow, afterthe mode is selected at the operation 1310 or 1312, the controller 202continues with the selected mode for a set period of time, such as 24hours, at an operation 1314. The controller 202 then repeats theoperations beginning at the operation 1302 to again set the mode that ismost appropriate at that time. Thus, the implantable medical device 102operates in a mode that may not be ideal for only as long as the setperiod of time in operation 1314.

While embodiments have been particularly shown and described, it will beunderstood by those skilled in the art that various other changes in theform and details may be made therein without departing from the spiritand scope of the invention.

What is claimed is:
 1. An implantable medical system, comprising: atleast one implantable medical lead comprising a first electrode and asecond electrode; an implantable medical device comprising: astimulation output electrically coupled to the first electrode; astimulation engine that provides a waveform to the stimulation output,the waveform including a stimulation pulse followed by an activerecharge pulse followed by a passive recharge followed by a period oftime of no recharge; a first sensing input electrically coupled to thesecond electrode; a differential amplifier connected to the firstsensing input; and a controller that obtains physiological signals fromthe differential amplifier during at least a portion of the period oftime of no recharge, the controller causing the stimulation to producethe waveform repeatedly.
 2. The implantable medical system of claim 1,wherein the controller obtains the physiological signals during at leasta portion of the passive recharge in addition to during the at least aportion of no recharge.
 3. The implantable medical system of claim 1,wherein the passive recharge occurs for an amount of time from 264-396microseconds.
 4. The implantable medical device of claim 1, wherein thestimulation engine delays 64-96 microseconds after termination of thestimulation pulse before providing the active recharge pulse and whereinthe stimulation engine delays 8-12 microseconds after termination of theactive recharge pulse before providing the passive recharge.
 5. Theimplantable medical device of claim 1, wherein the controller comparespeaks of the sensed physiological signal that occur over an amount oftime to a threshold, computes an average amount of time between each ofthe peaks that exceed the threshold, when the average amount of timebetween each of the peaks falls within a specified range, then causesthe stimulation engine to include the active recharge pulse followed bythe passive recharge after the stimulation pulse occurs and when theaverage amount of time between each of the peaks falls outside of thespecified range, then causes the stimulation engine to include only thepassive recharge instead of the active recharge pulse after thestimulation pulse terminates, and wherein the peaks correspond to peakcardiac activity when the average amount of time between each of thepeaks falls within the specified range, and wherein the specified rangespans from 0.375 seconds to 1.5 seconds.
 6. The implantable medicaldevice of claim 1, wherein the active recharge pulse has a baselinepulse amplitude, and wherein the controller measures a peak value of thephysiological signal measured from the sensing input, after thestimulation pulse of a next waveform terminates the stimulation engineprovides an active recharge pulse with a first adjusted pulse amplitudethat is different than the baseline pulse amplitude, and the stimulationengine repeats the waveform with the controller continuing to measurethe peak value a set number of times with the active recharge pulseamplitude being greater than the immediately prior active recharge pulseamplitude for each instance of providing the active recharge pulse, thecontroller determines which active recharge pulse amplitude correspondsto a smallest peak value and the stimulation engine continues to repeatthe waveform where the active recharge pulse of the repeated waveformhas the active recharge pulse amplitude that is determined to correspondto the smallest peak value.
 7. The implantable medical device of claim1, further comprising a second sensing input and wherein the at leastone lead comprises a third electrode electrically coupled to the secondsensing input, wherein the physiological signals comprise a neurologicalsignal that occurs as a differential signal between the first sensinginput and the second sensing input while the physiological signalscomprise a cardiac signal that occurs as a common mode signal betweenthe first sensing input and the second sensing input and whereinproviding the differential amplification of the physiological signalssensed at the first sensing input and the physiological signals sensedat the second sensing input comprises amplification of the neurologicalsignal while causing common mode rejection of the cardiac signal.
 8. Theimplantable medical device of claim 1, wherein the first electrode andthe second electrode are different electrodes.